药品名称DURAGESIC-100
申请号019813产品号001
活性成分FENTANYL市场状态处方药
剂型或给药途径FILM, EXTENDED RELEASE;TRANSDERMAL规格100MCG/HR
治疗等效代码AB参比药物
批准日期1990/08/07申请机构JANSSEN PHARMACEUTICALS INC
化学类型审评分类Standard review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
PED2006/11/20
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
019813071APLetter2016/10/04下载
019813067APLetter2016/04/22下载
019813066APLetter2015/07/02下载
019813065APLetter2014/08/20下载
019813063APLabel2014/04/16下载
019813063APLetter2014/04/17下载
019813060APLabel2013/09/24下载
019813060APLetter2013/10/09下载
019813056APLetter2013/04/16下载
019813052APLetter2012/07/11下载
019813052APLabel2012/07/12下载
019813051APLetter2012/07/11下载
019813044APLabel2010/04/01下载
019813044APReview2012/10/12下载
019813039APReview2009/01/12下载
019813039APLetter2005/02/08下载
019813039APLabel2005/02/08下载
019813036APLetter2003/06/08下载
019813036APLabel2003/06/08下载
019813036APReview2009/01/12下载
019813033APReview2012/09/17下载
019813033APLetter2008/02/14下载
019813033APLabel2008/02/14下载
019813030APReview2009/01/12下载
019813030APLetter2001/04/11下载
019813026APReview2009/01/12下载
019813025APReview2009/01/12下载
019813023APReview2009/01/12下载
019813023APLetter2001/04/11下载
019813021APReview2007/07/09下载
019813020APReview2007/07/09下载
019813019APReview2007/07/09下载
019813018APReview2007/07/09下载
019813000APReview2008/02/19下载
019813000APOther Important Information from FDA2005/07/29下载
019813000APMedication Guide2009/11/18下载
019813000APOther2012/07/11下载
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
019813071AP2016/09/30Supplement
019813067AP2016/04/20Supplement
019813066AP2015/06/26Supplement
019813065AP2014/08/19Supplement
019813064AP2014/06/08Manufacturing Change or Addition
019813063AP2014/04/16Labeling Revision
019813060AP2013/09/23Manufacturing Change or Addition
019813059AP2013/07/26Manufacturing Change or Addition
019813056AP2013/04/15Labeling Revision
019813055AP2012/12/19Manufacturing Change or Addition
019813052AP2012/07/09Labeling Revision
019813051AP2012/07/09Labeling Revision
019813044AP2009/07/31Labeling Revision
019813039AP2005/02/04New Dosage Regimen
019813036AP2003/05/20New or Modified Indication
019813033AP2008/02/07Labeling Revision
019813030AP2001/04/09Labeling Revision
019813029AP2000/11/09Control Supplement
019813028AP2000/11/09Control Supplement
019813027AP2000/04/26Control Supplement
019813026AP2000/11/01Labeling Revision
019813025AP2000/11/01Labeling Revision
019813024AP1999/12/02Control Supplement
019813023AP2001/04/11Labeling Revision
019813022AP1999/12/07Package Change
019813021AP1997/07/17Labeling Revision
019813020AP1997/07/17Labeling Revision
019813019AP1997/07/17Labeling Revision
019813018AP1997/07/17Labeling Revision
019813017AP1994/11/07Labeling Revision
019813016AP1994/03/29Labeling Revision
019813015AP1997/06/19Control Supplement
019813014AP1994/01/11Labeling Revision
019813012AP1993/10/25Labeling Revision
019813011AP1993/06/11Formulation Revision
019813010AP1993/07/28Labeling Revision
019813009AP1991/06/12Manufacturing Change or Addition
019813008AP1991/07/05Manufacturing Change or Addition
019813007AP1991/02/12Control Supplement
019813006AP1990/10/22Manufacturing Change or Addition
019813001AP1990/10/22Manufacturing Change or Addition
019813000AP1990/08/07Approval